You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Details for New Drug Application (NDA): 217738


✉ Email this page to a colleague

« Back to Dashboard


NDA 217738 describes NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Dr Reddys, Mylan, and Sciegen Pharms Inc, and is included in five NDAs. It is available from four suppliers. Additional details are available on the NAPROXEN AND ESOMEPRAZOLE MAGNESIUM profile page.

The generic ingredient in NAPROXEN AND ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium; naproxen. There are seventy-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.
Summary for 217738
Pharmacology for NDA: 217738
Suppliers and Packaging for NDA: 217738
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 217738 ANDA ScieGen Pharmaceuticals, Inc 50228-437 50228-437-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-437-10)
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 217738 ANDA ScieGen Pharmaceuticals, Inc 50228-437 50228-437-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-437-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE;375MG
Approval Date:Oct 11, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE;500MG
Approval Date:Oct 11, 2023TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.